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Gardasil Science Day presentations allege deceptive marketing

A Science Day presentation is shedding new light on the risks associated with the human papillomavirus (HPV) vaccine Gardasil, marketed for the prevention of HPV infections that can cause several kinds of cancers in men and women.

Science Day is a day for the lawyers on both sides to educate the court on the sorts of foundational knowledge required to understand the complex factual issues of the case that will be introduced at trial by expert witnesses and in documents. For example, a medical device case might involve questions of engineering (re: the product’s structural design) or chemistry (concerning the materials it’s made of). Drug cases usually involve some education about the condition the drug is intended to treat, the way the drug works (or is intended to work) in the body, and some broader education about the disease process for the injury claimed in the case (for example, cancer).

Jennifer Robi, now 24, had three Gardasil vaccines administered between March 2010 and January 2011, when she was 16 and 17 years old. Her parents chose to have her vaccinated based on Merck’s claims that the vaccine was safe and effective for the prevention of HPV.

According to Robi’s lawsuit, Merck left out certain details from its marketing materials, including potential risks. Within two months of her last Gardasil vaccination, Robi developed symptoms of Postural Orthostatic Tachycardia Syndrome (POTS), a condition in which there is an abnormally large increase in heart rate when a person changes from lying to standing. She was also diagnosed with small fiber neuropathy, a condition characterized by severe pain attacks, especially in the hands or feet. Her symptoms went on to include involuntary neuro-muscular contractions that left her debilitated. The former athlete and scholar eventually became wheelchair bound.

Robi’s case was originally brought in Vaccine Injury Compensation Program. After a judgment in the program, Robi elected to proceed to civil court with the argument that Merck committed fraud during clinical trials of Gardasil and failed to warn Robi and the public about the high risks of the vaccine compared to the minor benefits.

On Jan. 9, the Science Day Presentations began in Robi’s case against Merck and Kaiser Permanente in Los Angeles Superior Court. Robi’s attorneys demonstrated how Gardasil’s Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) adjunct overstimulated the immune systems of people who receive the vaccine causing autoimmune conditions that triggers redlining immune defenses to attack their bodies’ own organs. In Robi’s case, it resulted in damage and deterioration of organ systems throughout her body, the suit alleges.

AAHS has never been safely tested by government regulators or Merck. Animal studies showed that mice and sheep exposed to aluminum adjuvants developed strange behavioral patterns and illnesses consistent with autoimmune diseases.

Attorney Robert F. Kennedy, Jr., also presented evidence of fraudulent gimmicks used by Merck to deceive regulators during clinical trials, like using a toxic AAHS placebo rather than true inert placebo for control group participants. Half of the girls in the Gardasil group and half in the placebo group suffered serious injuries including several deaths, during the first seven months of the study, he said.

Sally Bryan offered the rebuttal on Merck’s behalf, telling the judge that the amount of aluminum in Gardasil was, essentially, substantial enough to harm someone’s immune system to prevent cancer for 50 years but small enough to cause no harm.

Both parties were ordered back to court on Feb. 9 to work out a discovery schedule.

Sources:
Collective Evolution
Courthouse News

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